Analytical Quality Assurance, Associate Director

Role: Associate Director, Quality Assurance (QC focus), overseeing QA activities related to analytical development and quality control in Cell & Gene therapy programs. Responsibilities include leading QA review and approval of analytical validation, transfer, stability testing, deviation investigations, root cause analysis, CAPA, and supporting regulatory submissions. Manages QA oversight of internal QC labs and external CDMOs, drafts quality agreements, and ensures compliance with FDA, EMA, and GMP standards. Leads digital quality initiatives leveraging AI, data analytics, and platforms like MES, LIMS, eQMS, supporting continuous improvement and quality metrics. Qualifications: Master's in scientific/health field; Ph.D. preferred; 8+ years in regulated pharma/biotech, with cell therapy experience. Skills in GxP QA/QC, analytical method development, regulatory knowledge, digital tools, and operational excellence methodologies (LEAN, Six Sigma). High-value: Cell & Gene therapy focus, analytical lifecycle management, regulatory compliance, digital quality systems, up to 15% travel. Work setup: on-site, five days/week with some flexibility.